FDA DeviceClass IINotable

FDA Recall: ALLURA Xper FD10F; System Code: 722002;

Date: 2026-04-08
Brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device
FDA Class: Class II

Description

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Hazard

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Remedy

10 units (8 US, 2 OUS)

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